Omega-3 supplements for children and teens with autism
Official title: Omega-3 Fatty Acids and Autism Spectrum Disorder (ASD) - A Double-blind Randomized Controlled Trial of Omega-3 Fatty Acids in Youth With ASD
Run by China Medical University Hospital · NCT07365553 · Data updated 2026-11-12
Over 12 weeks this study will see if omega-3 supplements help children and adolescents (ages 6–17) with autism by comparing omega-3 to a placebo.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 17 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Taichung, Taichung) |
| Status | Recruiting |
| Started | July 15, 2022 |
| Main results expected | June 30, 2026 |
| Study ends | July 31, 2026 |
| Registry record updated | January 26, 2026 |
| Trial ID | NCT07365553 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children and adolescents aged 6–17 with a DSM‑5 diagnosis of ASD who are not currently taking omega‑3 supplements, have had no recent medication or therapy changes, and do not have major psychiatric or physical comorbidities.
✕Probably not a fit
Patients with comorbid major psychiatric disorders (such as bipolar disorder, major depressive disorder, schizophrenia), significant physical illnesses, current omega‑3 use, or an allergy to omega‑3 are excluded and are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a 12-week interventional study enrolling children and adolescents aged 6–17 with a DSM-5 diagnosis of autism spectrum disorder. Participants will receive either omega-3 polyunsaturated fatty acids or a matching placebo and will be followed with scheduled visits. The primary outcome is change in clinical symptoms measured by the Aberrant Behavior Checklist (ABC); secondary outcomes include inflammatory biomarkers, cognitive testing, and physiological measures such as heart-rate variability. Key eligibility criteria exclude current omega-3 use and major psychiatric or physical comorbidities, and all visits occur at China Medical University Hospital in Taichung.
Why it matters
Potential benefit: If effective, omega-3 supplementation could modestly reduce behavioral symptoms and inflammation, offering a low-risk adjunct treatment for youth with ASD.
How similar studies have gone: Previous small trials of omega‑3 in ASD have produced mixed and generally modest results, so the approach is plausible but not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosis of DSM5 ASD made by child and adolescent psychiatrist * age 6-17 years-old at the time of enrolment * no pharmacotherapy or non-pharmacotherapy adjustment within the past 4 weeks, * Signed informed consent. Exclusion Criteria: * comorbid other psychiatric disorders, including schizophrenia or affective mood disorder (Bipolar and Major Depressive Disorder), or substance use disorder * comorbid physical disorders, such as thyroid dysfunction, cerebral palsy, coagulation disorders * currently using omega-3 supplements or probiotics * allergy to omega-3.
Where it's running
-
China Medical University
Taichung, Taichung, Taiwan Recruiting
Study contacts
- Principal investigator: Pei-Chen Chang, MD, PhD — China Medical University Hospital
- Study coordinator: Pei-Chen Chang, MD, PhD
- Email: d13121@mail.cmuh.org.tw
- Phone: 0422052121
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.